Analytical Development Project Lead

neurocrine; San Diego (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Neurocrine Biosciences in San Diego is seeking an Analytical project leader to drive analytical chemistry research, developing assays and supporting manufacturing of API and drug products for preclinical and clinical studies.

You will establish, validate, and document methods, ensuring regulatory compliance and quality throughout development and transfer processes. Strong cross-functional collaboration is essential.

Qualifications

• BS/BA in chemistry or closely related field with 5+ years in pharmaceutical analytical chemistry.
• MS/MA in chemistry with 3+ years in analytical chemistry is acceptable.
• PhD with relevant experience may substitute; strong knowledge of ICH/FDA guidance is required.

Responsibilities

• Act as an analytical project leader for API and drug product development.
• Develops, validates, and transfers analytical methods for drug substances and products.
• Oversees testing of analytical samples and ensures compliance with cGMP and regulatory requirements.
• Collaborates with cross-functional teams including pharmaceutical sciences and manufacturing.

Skills

Analytical chemistry

Project management

cGMP compliance

Problem solving

Regulatory understanding

Education

BS/BA in Chemistry

MS/MA in Chemistry

PhD in Chemistry

Tools

HPLC

Mass spectrometry

Regulatory compliance software

Job description

Neurocrine Biosciences in San Diego is seeking an Analytical project leader to drive analytical chemistry research, developing assays and supporting manufacturing of API and drug products for preclinical and clinical studies.

You will establish, validate, and document methods, ensuring regulatory compliance and quality throughout development and transfer processes. Strong cross-functional collaboration is essential.